Chemist

2+ years' experience with HPLC required. All other job duties can be trained!

Position Summary

We are seeking a detail-oriented and proactive Associate Scientist to join our cGMP API Stability Laboratory. This role is responsible for supporting analytical stability studies in compliance with regulatory guidelines. The ideal candidate will have hands-on experience with small molecule drug substances and drug product batch release and stability testing, as well as experience working in cGMP and GLP environments.

• Essential Responsibilities Perform stability testing using techniques such as HPLC, GC, KF, XRD, DSC, TGA, and PSD within a cGMP-regulated laboratory.
• Coordinate the timely and compliant generation of stability data to support client projects.
• Author and review stability protocols, reports and related documentation.
• Conduct out of specification (OOS) investigations, identify potential root causes, and support implementation of corrective and preventative actions (CAPA).
• Review laboratory data for technical accuracy, completeness, and compliance with regulatory requirements.
• Manage laboratory inventory, stability chambers, and associated information systems.
• Collaborate with internal teams and clients to design appropriate batch release and stability studies for APIs and drug products.
• Develop and maintain knowledge of applicable ICH, FDA, EMA and GLP guidelines.

Qualifications

• Education and Experience: Bachelor’s degree in Chemistry or a related scientific discipline required.
• Minimum of 2 + years of relevant analytical laboratory experience in a cGMP environment, or an equivalent combination of education and experience.
• Relevant experience in a quality control or stability laboratory is essential.
• Skills and Competencies Hands-on experience with standard analytical laboratory instrumentation (e.g., HPLC, analytical balances, pH meters, titrators, etc.)
• Familiarity with ICH stability guidelines preferred.
• Experience working in a cGMP compliant laboratory environment is preferred.
• Proficiency in laboratory techniques such as assay, impurity testing, sample preparations, dilutions, etc.
• Strong proficiency in Microsoft Word and Excel
• Experience with OOS investigations and root cause analysis is preferred.
• Solid understanding of arithmetic, algebra, and basic statistical concepts.
• Strong written and verbal communication skills with the ability to interact effectively with clients and cross-functional teams.
• Proven ability to manage multiple priorities and work effectively in a fast-paced environment.